Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

UCB

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Rotigotine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338896

2010-024250-11 (EudraCT Number)

SP1066

Details and patient eligibility

About

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment

Exclusion criteria

• Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such
• Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Sequence A-B

Experimental group

Description:

4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1)

Treatment:

Drug: Rotigotine transdermal patch

Sequence B-A

Experimental group

Description:

4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1)

Treatment:

Drug: Rotigotine transdermal patch